CMS Withdrawal of Blood Glucose Meter Memorandum
In a previous blog on March 1, I discussed implications of the letter sent by Centers for Medicare and Medicaid Services (CMS) to state survey agency directors on November 21, 2014 that addressed off-label use of waived blood glucose monitoring systems (BGMS). CLIA surveyors were instructed to determine whether a health care institution was using BGMS according to the manufacturer’s instructions or off-label. Since neither FDA nor CMS had defined critically ill patient populations, each institution was expected to define them in order to understand when use of glucose meters may be off-label and therefore high complexity.
On March 13, 2015, CMS sent a follow-up letter to state survey agency directors announcing that it was temporarily withdrawing the previous memorandum and reissuing it in draft form only to allow more time for feedback regarding the use of waived BGMS in hospital settings for off-label applications. Therefore, it appears that CMS is no longer instructing CLIA surveyor(s) to assess how a health care institution is using blood glucose meters for critically ill patients.
